Methods for Gas Filtration in Fluid Processing Systems

ABSTRACT

A method for filtering a gas comprises passing a gas through a compartment of a filter assembly, the filter assembly comprising: an inlet opening; a first outlet opening; a casing comprising polymeric film and bounding the compartment, the compartment communicating with the inlet opening and the first outlet opening; and a first filter at least partially disposed within the compartment. The method further comprising forming a first seal across a first section of the casing at a location between the inlet opening and the first filter to form a first sub-compartment within the casing and severing the casing at a first location.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No.16/854,358, filed Apr. 21, 2020, which is a divisional of U.S.application Ser. No. 14/587,976, filed Dec. 31, 2014, now U.S. Pat. No.10,688,429, issued on Jun. 23, 2020, which claims the benefit of U.S.Provisional Application No. 61/968,779, filed Mar. 21, 2014, which areincorporated herein by specific reference.

BACKGROUND OF THE INVENTION 1. The Field of the Invention

The present invention relates to gas filter systems used with fluidprocessing systems and methods for using such gas filter systems.

2. The Relevant Technology

Bioreactors are used in the growth of cells and microorganisms. Atypical bioreactor includes a container which holds a suspensioncomprised of liquid growth media, a culture of cells or microorganisms,and other desired nutrients and components. A rotatable impeller isoperated within the suspension to maintain the suspension in asubstantially homogenous state. Small gas bubbles are continuouslysparged into the suspension and are typically used to help oxygenate theculture, strip out unwanted CO₂ from the suspension and control the pHof the suspension.

To maintain the viability of the culture, the compartment in which theculture is being grown must remain sterile. To remove the sparged gasthat is being continuously added to the suspension while maintainingsterility of the compartment, the gas is typically removed through afilter system. One conventional filter system is referred to as acartridge filter system and includes a rigid, metal housing into which acartridge filter is removably positioned. Gas from the container isdelivered to an inlet on the housing. The gas then travels through thefilter within the housing and is then expelled to the environmentthrough an outlet on the housing. The filter prevents any biologicalmatter within the container from being expelled into the environment andprevents any contaminates in the environment from entering into thecontainer.

Although useful, the conventional cartridge filter system has a numberof shortcomings. For example, the metal housing in which the cartridgefilter is placed is time consuming and labor intensive to maintainbecause it must be cleaned and sterilized between each use. Cleaning themetal housing can introduce chemical contaminants and leave productionresiduals. Furthermore, in addition to being expensive to purchase, themetal housing is cumbersome, both because it is a stand-alone item thatoccupies substantial space around the bioreactor and because it requiresa relatively long length of tubing that must be run from the containerand then sterilely connected to the housing. In addition, because thefilter slowly clogs during use, the problems are compounded becausemultiple filter housings must be connected in parallel to ensure thatthe process can be continuously operated until the culture is fullygrown.

In one attempt to address some of the above shortcomings, capsulefilters have also been used with bioreactors. A capsule filter comprisesa rigid plastic housing that permanently encases a filter. Althoughcapsule filters are disposable and thus do not need to be cleaned orsterilized, they have their own drawbacks. For example, capsule filtersare designed to be capable of operating at relatively high pressures andare typically rated for about 500 kPa. To enable operation at thispressure, the plastic housing is required to be relatively thick,thereby increasing the expense to the filter and making it relativelylarge and bulky. Furthermore, the capsule filters have a relativelysmall inlet and outlet port through which the gas travels. As a resultof the small diameter ports, if a large gas flow rate is beingprocessed, the system must either be operated at a high gas pressure,which can be undesirable in some circumstances, or multiple filters mustbe used, which increases cost and complexity.

The sparge gas passing through the suspension will carry moisture towardthe filter assembly. Moisture that condenses on the filters will clogthe filters. To limit the rate at which the filters are clogged, acondenser system can be placed between the reactor container and thefilter system. The condenser system removes a portion of the moisturefrom the gas before it reaches the filter system. Traditional condensersystems, however, are often inconvenient to use in that they aretypically complex, stand-alone systems that require multiple tubes thatneed sterile connections with the container and filter assembly.Furthermore, the condenser systems typically restrict the gas flow rateand thereby require that the system be operated at an elevated pressure.Condenser system can also be difficult to adjust for different gas flowrates.

Accordingly, what is needed in the art are condenser systems andfiltration systems that can be used with bioreactors and other fluidprocessing systems that solve some or all of the above problems.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present invention will now be discussed withreference to the appended drawings. It is appreciated that thesedrawings depict only typical embodiments of the invention and aretherefore not to be considered limiting of its scope.

FIG. 1 is a perspective view of a fluid processing system including acondenser system and a filter system;

FIG. 2 is a perspective view of a container of the system shown in FIG.2 with a mixing system;

FIG. 3 is a partially exploded view of the mixer system shown in FIG. 2;

FIG. 4 is an exploded view of an impeller assembly and drive shaft ofthe mixing system shown in FIG. 3 ;

FIG. 5 is an enlarged perspective view of portions of the condensersystem and filter system shown in FIG. 1 ;

FIG. 6 is a perspective view of the condenser shown in FIG. 5 in anopened position;

FIG. 7 is a partially exploded view of the condenser shown in FIG. 6 ;

FIG. 8 is a partially disassembled view of the condenser shown in FIG. 6;

FIG. 9 is a right side perspective view of the system components shownin FIG. 5 ;

FIG. 10 is a perspective view of a condenser bag that is used with thecondenser shown in FIG. 6 ;

FIG. 11 is a partially exploded view of the condenser bag shown in FIG.10 with ports that can be coupled therewith;

FIG. 12 is a perspective view of an alternative embodiment of thecondenser bag shown in FIG. 10 ;

FIG. 12A is a perspective view of an alternative embodiment of thecondenser bag shown in FIG. 12 ;

FIG. 13 is a perspective view of another alternative embodiment of acondenser bag that can be coupled with the container shown in FIG. 1 byuse of a single port;

FIG. 14 is an enlarged perspective view of the filter system shown inFIG. 1 ;

FIG. 14A is a bottom perspective view of the filter system shown in FIG.14 ;

FIG. 15 is a perspective view of the filter assembly of the filtersystem shown in FIG. 14 ;

FIG. 16 is an exploded view of a portion of the filter system shown inFIG. 14 ;

FIG. 17 is a cross sectional side view of the portion of the filterassembly shown in FIG. 15 ;

FIG. 17A is a cross sectional side view of an alternative embodiment ofthe portion of the filter assembly shown in FIG. 17 ;

FIG. 18 is a cross sectional side view of an alternative embodiment ofthe filter assembly shown in FIG. 15 that includes a single filter;

FIG. 19 is a perspective view of an alternative embodiment of the filterassembly shown in FIG. 15 that includes two filters;

FIG. 20 is a perspective view of the filter system shown in FIG. 14having an automated clamping system coupled thereto;

FIG. 21 is a perspective view of the filter system shown in FIG. 20 witha portion of the filter assembly being separated for integrity testingof the filter;

FIG. 22 is a perspective view of the filter assembly shown in FIG. 15being coupled to the condenser bag by a single port;

FIG. 23 is a perspective view of the filter assembly and condenser bagbeing integrally formed using a single continuous bag;

FIG. 24 is a perspective view of an alternative embodiment of a filterassembly that is modular; and

FIG. 25 is a perspective view of the filter assembly shown in FIG. 15being directly coupled with the container in FIG. 1 .

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Before describing the present disclosure in detail, it is to beunderstood that this disclosure is not limited to particularlyexemplified apparatus, systems, methods, or process parameters that may,of course, vary. It is also to be understood that the terminology usedherein is only for the purpose of describing particular embodiments ofthe present invention, and is not intended to limit the scope of theinvention in any manner.

All publications, patents, and patent applications cited herein, whethersupra or infra, are hereby incorporated by reference in their entiretyto the same extent as if each individual publication, patent, or patentapplication was specifically and individually indicated to beincorporated by reference.

The term “comprising” which is synonymous with “including,”“containing,” “having” or “characterized by,” is inclusive or open-endedand does not exclude additional, unrecited elements or method steps.

It will be noted that, as used in this specification and the appendedclaims, the singular forms “a,” “an” and “the” include plural referentsunless the content clearly dictates otherwise. Thus, for example,reference to a “port” includes one, two, or more ports.

As used in the specification and appended claims, directional terms,such as “top,” “bottom,” “left,” “right,” “up,” “down,” “upper,”“lower,” “proximal,” “distal” and the like are used herein solely toindicate relative directions and are not otherwise intended to limit thescope of the invention or claims.

Where possible, like numbering of elements have been used in variousfigures. Furthermore, multiple instances of an element and orsub-elements of a parent element may each include separate lettersappended to the element number. For example two instances of aparticular element “91” may be labeled as “91 a” and “91 b”. In thatcase, the element label may be used without an appended letter (e.g.,“91”) to generally refer to instances of the element or any one of theelements. Element labels including an appended letter (e.g., “91 a”) canbe used to refer to a specific instance of the element or to distinguishor draw attention to multiple uses of the element. Furthermore, anelement label with an appended letter can be used to designate analternative design, structure, function, implementation, and/orembodiment of an element or feature without an appended letter.Likewise, an element label with an appended letter can be used toindicate a sub-element of a parent element. For instance, an element“12” can comprise sub-elements “12 a” and “12 b.”

Various aspects of the present devices and systems may be illustrated bydescribing components that are coupled, attached, and/or joinedtogether. As used herein, the terms “coupled”, “attached”, “connected”and/or “joined” are used to indicate either a direct connection betweentwo components or, where appropriate, an indirect connection to oneanother through intervening or intermediate components. In contrast,when a component is referred to as being “directly coupled”, “directlyattached”, “directly connected” and/or “directly joined” to anothercomponent, there are no intervening elements present.

Various aspects of the present devices, systems, and methods may beillustrated with reference to one or more exemplary embodiments. As usedherein, the term “embodiment” means “serving as an example, instance, orillustration,” and should not necessarily be construed as preferred oradvantageous over other embodiments disclosed herein.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which the present disclosure pertains. Although a number ofmethods and materials similar or equivalent to those described hereincan be used in the practice of the present disclosure, the preferredmaterials and methods are described herein.

The present invention relates to condenser systems, filter systems andto processing systems and methods for mixing and sparging solutionsand/or suspensions that incorporate such condenser systems and filtersystems. The processing systems can be bioreactors or fermenters usedfor culturing cells or microorganisms. By way of example and not bylimitation, the inventive systems can be used in culturing bacteria,fungi, algae, plant cells, animal cells, protozoans, nematodes, and thelike. The systems can accommodate cells and microorganisms that areaerobic or anaerobic and are adherent or non-adherent. The systems canalso be used in association with the formation and/or treatment ofsolutions and/or suspensions that are not biological but neverthelessincorporate mixing and sparging. For example, the systems can be used inthe production of media, chemicals, food products, beverages, and otherliquid products which require sparging with a gas.

The inventive systems are designed so that a majority of the systemcomponents that contact the material being processed can be disposed ofafter each use. As a result, the inventive systems substantiallyeliminate the burden of cleaning and sterilization required byconventional stainless steel mixing and processing systems. This featurealso ensures that sterility can be consistently maintained duringrepeated processing of multiple batches. In view of the foregoing, andthe fact that the inventive systems are easily scalable, relatively lowcost, and easily operated, the inventive systems can be used in avariety of industrial and research facilities that previously outsourcedsuch processing.

Depicted in FIG. 1 is one embodiment of an inventive fluid processingsystem 10 incorporating features of the present invention. In general,processing system 10 comprises a container 12 that is disposed within arigid support housing 14 and that is coupled with a condenser system 16.A filter system 17 is coupled with condenser system 16 and functions toboth filter gas exiting from condenser system 17 and preventcontaminates from entering container 12. A mixer system 18 is designedfor mixing and/or suspending components within container 12. The variouscomponents of fluid processing system 10 will now be discussed ingreater detail.

With continued reference to FIG. 1 , support housing 14 has asubstantially cylindrical sidewall 20 that extends between an upper end22 and an opposing lower end 24. Lower end 24 has a floor 26 mountedthereto. Support housing 14 has an interior surface 28 that bounds achamber 30. An annular lip 32 is formed at upper end 22 and bounds anopening 34 to chamber 30. Floor 26 of support housing 14 rests on a cart36 having wheels 38. Support housing 14 is removable secured to cart 36by connectors 40. Cart 36 enables selective movement and positioning ofsupport housing 14. In alternative embodiments, however, support housing14 need not rest on cart 36 but can rest directly on a floor or otherstructure.

Although support housing 14 is shown as having a substantiallycylindrical configuration, in alternative embodiments support housing 14can have any desired shape capable of at least partially bounding acompartment. For example, sidewall 20 need not be cylindrical but canhave a variety of other transverse, cross sectional configurations suchas polygonal, elliptical, or irregular. Furthermore, it is appreciatedthat support housing 14 can be scaled to any desired size. For example,it is envisioned that support housing 14 can be sized so that chamber 30can hold a volume of less than 50 liters or more than 1,000 liters.Support housing 14 is typically made of metal, such as stainless steel,but can also be made of other materials capable of withstanding theapplied loads of the present invention.

In one embodiment of the present invention means are provided forregulating the temperature of the fluid that is contained withincontainer 12 disposed within support housing 14. By way of example andnot by limitation, electrical heating elements can be mounted on orwithin support housing 14. The heat from the heating elements istransferred either directly or indirectly to container 12.Alternatively, in the depicted embodiment support housing 14 is jacketedwith one or more fluid channels being formed therein. The fluid channelshave a fluid inlet 42 and a fluid outlet 44 that enables a fluid, suchas water or propylene glycol, to be pumped through the fluid channels.By heating, cooling or otherwise controlling the temperature of thefluid that is passed through the fluid channels, the temperature ofsupport housing 14 can be regulated which in turn regulates thetemperature of the fluid within container 12 when container 12 isdisposed within support housing 14. Other conventional means can also beused such as by applying gas burners to support housing 14 or pumpingthe fluid out of container 12, heating or cooling the fluid and thenpumping the fluid back into container 12. When using container 12 aspart of a bioreactor or fermenter, the means for heating can be used toheat the culture within container 12 to a temperature in a range betweenabout 30° C. to about 40° C. Other temperatures can also be used.

Support housing 14 can have one or more opening 46 formed on the lowerend of sidewall 20 and on floor 26 to enable gas and fluid lines tocouple with container 12 and to enable various probes and sensors tocouple with container 12 when container 12 is within support housing 14.Further disclosure on support housing 14 and alternative designs thereofis disclosed in U.S. Pat. No. 7,682,067 and US Patent Publication No.2011-0310696, which are incorporated herein by specific reference.

FIG. 2 shows container 12 coupled with mixer system 18. Container 12 hasa side 55 that extends from an upper end 56 to an opposing lower end 57.Container 12 also has an interior surface 58 that bounds a compartment50 in which a portion of mixer system 18 is disposed. In the embodimentdepicted, container 12 comprises a flexible bag. Formed on container 12are a plurality of ports 51 that communicate with compartment 50.Although only two ports 51 are shown, it is appreciated that container12 can be formed with any desired number of ports 51 and that ports 51can be formed at any desired location on container 12 such as upper end56, lower end 57, and/or alongside 55. Ports 51 can be the sameconfiguration or different configurations and can be used for a varietyof different purposes. For example, ports 51 can be coupled with fluidlines for delivering media, cell cultures, and/or other components intoand out of container 12.

Ports 51 can also be used for coupling probes to container 12. Forexample, when container 12 is used as a bioreactor for growing cells ormicroorganisms, ports 51 can be used for coupling probes such astemperatures probes, pH probes, dissolved oxygen probes, and the like.Examples of ports 51 and how various probes and lines can be coupledthereto is disclosed in United States Patent Publication No.2006-0270036, published Nov. 30, 2006 and United States PatentPublication No. 2006-0240546, published Oct. 26, 2006, which areincorporated herein by specific reference. Ports 51 can also be used forcoupling container 12 to secondary containers and to other desiredfittings.

As also depicted in FIG. 2 , an exhaust port 92 is mounted on upper end56 of container 12 and is used for coupling with condenser system 16. Asdepicted in FIG. 11 , exhaust port 92 includes a stem 93 having aninterior surface 94 and an opposing exterior surface 95 that extendbetween a first end and an opposing second end. Encircling and radiallyoutwardly projecting from the first end is a mounting flange 96.Mounting flange 96 is welded or otherwise secured to interior surface 58of container 12 (FIG. 2 ) so that stem 93 projects out through anopening on container 12. Interior surface 58 bounds a port opening 97that extends through stem 93 and communicates with compartment 50 ofcontainer 12. In the depicted embodiment, port opening 97 has a circulartransverse cross section. Other configurations can also be used such aselliptical, polygonal, irregular or the like. The transverse crosssection of port opening 97 typically has a maximum diameter in a rangebetween about 0.5 cm to about 15 cm with about 2 cm to about 10 cm beingmore common. For high gas throughput, the maximum diameter is typicallygreater than 3 cm, 4 cm, 5 cm or 6 cm. Other dimensions can also be useddepending on the application.

Encircling and outwardly projecting from exterior surface 95 of stem 93at a location between the opposing ends is a retention flange 98.Encircling and outwardly projecting from the second end of stem 93 is acoupling flange 99. Coupling flange 99 has a top surface 101 with anannular seal 103 formed thereon. A first annular groove 108 is formedbetween mounting flange 96 and retention flange 98 while a secondannular groove 109 is formed between retention flange 98 and couplingflange 99. The body of exhaust port 92 is typically molded from apolymeric material and is more rigid than container 12. Annular seal 103is typically formed from an elastomeric material that is more flexiblethan the port body on which it is attached. The use of exhaust port 92will be discussed below in greater detail.

In one embodiment of the present invention, means are provided fordelivering a gas into the lower end of container 12. By way of exampleand not by limitation, as also depicted in FIG. 2 , a sparger 54 can beeither positioned on or mounted to lower end 57 of container 12 fordelivering a gas to the fluid within container 12. As is understood bythose skilled in the art, various gases are typically required in thegrowth of cells or microorganisms within container 12. The gas typicallycomprises air that is selectively combined with oxygen, carbon dioxideand/or nitrogen. However, other gases can also be used. The addition ofthese gases can be used to regulate the dissolved oxygen and CO₂ contentand to regulate the pH of a culture solution. Depending on theapplication, sparging with gas can also have other applications. A gasline 61 is coupled with sparger 54 for delivering the desired gas tosparger 54. Gas line 61 need not pass through lower end 57 of container12 but can extend down from upper end 56 or from other locations.

Sparger 54 can have a variety of different configurations. For example,sparger 54 can comprise a permeable membrane or a fritted structurecomprised of metal, plastic or other materials that dispense the gas insmall bubbles into container 12. Smaller bubbles can permit betterabsorption of the gas into the fluid. In other embodiments, sparger 54can simply comprise a tube, port, or other type opening formed on orcoupled with container 12 through which gas is passed into container 12.In contrast to being disposed on container 12, the sparger can also beformed on or coupled with mixer system 18. Examples of spargers and howthey can be used in the present invention are disclosed in United StatesPatent Publication Nos. 2006-0270036 and 2006-0240546 which werepreviously incorporated by reference. Other conventional spargers canalso be used.

In the depicted embodiment, container 12 has an opening 52 that issealed to a rotational assembly 82 of mixer system 18, which will bediscussed below in greater detail. As a result, compartment 50 is sealedclosed so that it can be sterilized and be used in processing sterilefluids. During use, container 12 is disposed within chamber 30 ofsupport housing 14 as depicted in FIG. 1 . Container 12 is supported bysupport housing 14 during use and can subsequently be disposed offollowing use. In one embodiment, container 12 comprised of a flexible,water impermeable material such as a low-density polyethylene or otherpolymeric sheets or film having a thickness in a range between about 0.1mm to about 5 mm with about 0.2 mm to about 2 mm being more common.Other thicknesses can also be used. The material can be comprised of asingle ply material or can comprise two or more layers which are eithersealed together or separated to form a double wall container. Where thelayers are sealed together, the material can comprise a laminated orextruded material. The laminated material comprises two or moreseparately formed layers that are subsequently secured together by anadhesive.

The extruded material comprises a single integral sheet that comprisestwo or more layers of different materials that can be separated by acontact layer. All of the layers are simultaneously co-extruded. Oneexample of an extruded material that can be used in the presentinvention is the CX3-9 film available from Thermo Fisher Scientific. TheCX3-9 film is a three-layer, 9 mil cast film produced in a cGMPfacility. The outer layer is a polyester elastomer coextruded with anultra-low density polyethylene product contact layer. Another example ofan extruded material that can be used in the present invention is theCX5-14 cast film also available from Thermo Fisher Scientific. TheCX5-14 cast film comprises a polyester elastomer outer layer, anultra-low density polyethylene contact layer, and an EVOH barrier layerdisposed therebetween.

The material is approved for direct contact with living cells and iscapable of maintaining a solution sterile. In such an embodiment, thematerial can also be sterilizable such as by radiation. Examples ofmaterials that can be used in different situations are disclosed in U.S.Pat. No. 6,083,587 which issued on Jul. 4, 2000 and United States PatentPublication No. US 2003-0077466 A1, published Apr. 24, 2003, which arehereby incorporated by specific reference.

In one embodiment, container 12 comprise a two-dimensional pillow stylebag wherein two sheets of material are placed in overlapping relationand the two sheets are bounded together at their peripheries to form theinternal compartment. Alternatively, a single sheet of material can befolded over and seamed around the periphery to form the internalcompartment. In another embodiment, the containers can be formed from acontinuous tubular extrusion of polymeric material that is cut to lengthand is seamed closed at the ends.

In still other embodiments, container 12 can comprise athree-dimensional bag that not only has an annular side wall but also atwo dimensional top end wall and a two dimensional bottom end wall.Three dimensional containers comprise a plurality of discrete panels,typically three or more, and more commonly four or six. Each panel issubstantially identical and comprises a portion of the side wall, topend wall, and bottom end wall of the container. Corresponding perimeteredges of each panel are seamed together. The seams are typically formedusing methods known in the art such as heat energies, RF energies,sonics, or other sealing energies.

In alternative embodiments, the panels can be formed in a variety ofdifferent patterns. Further disclosure with regard to one method ofmanufacturing three-dimensional bags is disclosed in United StatesPatent Publication No. US 2002-0131654 A1, published Sep. 19, 2002,which is hereby incorporated by reference.

It is appreciated that container 12 can be manufactured to havevirtually any desired size, shape, and configuration. For example,container 12 can be formed having a compartment sized to 10 liters, 30liters, 100 liters, 250 liters, 500 liters, 750 liters, 1,000 liters,1,500 liters, 3,000 liters, 5,000 liters, 10,000 liters or other desiredvolumes. The size of the compartment can also be in the range betweenany two of the above volumes. Although container 12 can be any shape, inone embodiment container 12 is specifically configured to becomplementary or substantially complementary to chamber 30 of supporthousing 14. It is desirable that when container 12 is received withinchamber 30, container 12 is at least generally uniformly supported bysupport housing 14. Having at least general uniform support of container12 by support housing 14 helps to preclude failure of container 12 byhydraulic forces applied to container 12 when filled with fluid.

Although in the above discussed embodiment container 12 has a flexible,bag-like configuration, in alternative embodiments it is appreciatedthat container 12 can comprise any form of collapsible container orsemi-rigid container. Container 12 can also be transparent or opaque andcan have ultraviolet light inhibitors incorporated therein.

Mixer system 18 is used for mixing and/or suspending a culture or othersolution within container 12. As depicted in FIGS. 2 , mixer system 18generally comprises a drive motor assembly 59 that is mounted on supporthousing 14 (FIG. 1 ), a impeller assembly 78 coupled to and projectsinto container 12, and a drive shaft 72 (FIG. 4 ) that extends betweendrive motor assembly 59 and impeller assembly 78.

Turning to FIG. 3 , drive motor assembly 59 comprises a housing 60having a top surface 62 and an opposing bottom surface 64 with anopening 66 extending through housing 60 between surfaces 62 and 64. Atubular motor mount 68 is rotatably secured within opening 66 of housing60. A drive motor 70 is mounted to housing 60 and engages with motormount 68 so as to facilitate select rotation of motor mount 68 relativeto housing 60. As depicted in FIG. 1 , drive motor assembly 59 iscoupled with support housing 14 by a bracket 53. In alternativeembodiments, however, drive motor assembly 59 can be mounted on aseparate structure adjacent to support housing 14.

Drive shaft 72 is configured to pass through motor mount 68 and thusthrough housing 60. Turning to FIG. 4 , drive shaft 72 comprises a headsection 74 and a shaft section 76 that are either connected together orintegrally formed as a single piece. Impeller assembly 78 comprises anelongated tubular connector 80 having rotational assembly 82 secured atone end and an impeller 84 secured to the opposing end. Rotationalassembly 82 comprises an outer casing 86 and a tubular hub 88 thatcentrally extends through outer casing 86 and is rotatably coupledthereto. One or more dynamic seals can be formed between outer casing 86and tubular hub 88 so that a sterile seal can be maintainedtherebetween. As depicted in FIG. 2 , outer casing 86 is secured tocontainer 12 so that tubular connector 80, which is coupled with hub 88,extends into compartment 50 of container 12. Impeller 84, which isdisposed on the end of connector 80, is also disposed within compartment50 of container 12.

During use, container 12 with impeller assembly 78 secured thereto arepositioned within chamber 30 of support housing 14. Rotational assembly82 is then removably connected to bottom surface 64 of housing 60 ofdrive motor assembly 59 so that hub 88 is aligned with motor mount 68.The distal end of drive shaft 72 is advanced down through motor mount68, through hub 88 of rotational assembly 82, and through tubularconnector 80. Finally, the distal end of drive shaft 72 is receivedwithin a socket on impeller 84 so that rotation of drive shaft 72facilitates rotation of impeller 84.

With drive shaft 72 engaging impeller 84, a driver portion 90 (FIG. 4 )of drive shaft 72 is received within and engages hub 88 so that rotationof draft shaft 72 also rotates hub 88. Because outer casing 86 issecured to housing 60, hub 88 rotates relative to casing 86 and housing60 as drive shaft 72 is rotated. It is further noted that tubularconnector 80 also rotates concurrently with impeller 84, hub 88 anddrive shaft 72.

Finally, once drive shaft 72 is fully passed through motor mount 68,head section 74 of drive shaft 72 engages motor mount 68. Accordingly,as motor 70 facilitates rotation of motor mount 68, motor mount 68facilitates rotation of drive shaft 72. In turn, as discussed above,drive shaft 72 facilitates rotation of hub 88, connector 80 and impeller84. Rotation of impeller 84 facilities mixing and suspension of thefluid within compartment 50 of container 12. Further disclosure withregard to mixer system 18, the operation thereof, and alternativeembodiments thereof are disclosed in United States Patent PublicationNo. 2011-0188928 A1, published Aug. 4, 2011, which is incorporatedherein by specific reference.

The above described mixer system 18 and the alternatives theretocomprise one embodiment of means for mixing fluid contained withincontainer 12. In alternative embodiments, it is appreciated that mixersystem 18 can be replaced with a variety of other mixing systems. Forexample, mixer system 18 can be replaced with a conventional rigid driveshaft that projects into container 12 through a dynamic seal and has animpeller or other mixing element mounted on the end thereof. Externalrotation of the drive shaft thus facilitates rotation of the impeller orother mixing element which mixes and/or suspends the fluid withincontainer 12.

In another embodiment, the drive shaft projecting into container 12 canbe configured to repeatedly rise and lower a mixing element locatedwithin container 12 for mixing the fluid. Alternatively, a magnetic stirbar can be disposed within compartment 50 of container 12 and rotated bya magnetic mixer disposed outside of container 12. In yet otherembodiments, a stir bar, paddle, or the like that projects intocompartment 50 of container 12 can be pivoted, swirled or otherwisemoved to mix the fluid. In addition, the mixing can be accomplished bycirculating fluid through compartment 50, such as by using a peristalticpump to move the fluid into and out of compartment 50 through a tubehaving opposing ends sealed to container 12. Gas bubbles can also bepassed through the fluid to achieve the desired mixing. Finally, supporthousing 14 and container 12 can be pivoted, rocked, rotated or otherwisemoved so as to mix the fluid within container 12. Other conventionalmixing techniques can also be used. Specific examples of how toincorporate a mixer into a flexible bag, such as container 12, aredisclosed in U.S. Pat. No. 7,384,783, issued Jun. 10, 2008; U.S. Pat.No. 7,682,067, issued Mar. 23, 2010; and US Patent Publication No.2006/0196501, published Sep. 7, 2006 which are incorporated herein byspecific reference.

Retuning to FIG. 1 , condenser system 16 generally comprises a condenser100, a condenser bag 102, a chiller 104, and a pump 106. Turning to FIG.5 , condenser 100 comprises a first panel 110A and a second panel 110Bthat are hingedly coupled together by a bracket 140. As depicted in FIG.6 , first panel 110A includes interior face 114A and an opposingexterior face 116A that extend between an inside edge 118A and anoutside edge 120A. First panel 110A also includes a top edge 122A and anopposing bottom edge 124A. Edges 118A, 120A, 122A and 124A combine toform a perimeter edge 123A that encircles panel 110A. An enlarged notch129A is formed on top edge 122A at the intersection with outside edge120A. As such, top edge 122A includes a first section 125A inwardlyextending from outside edge 120A, a third section 127A inwardlyextending from inside edge 118A and a second section 126A upwardlyextending from first section 125A to third section 127A. Notch 129A isbounded by sections 125A and 126A which can extend orthogonally to eachother to form an inside corner having a substantially square orrectangular configuration. However, other configurations can also beused. For example, sections 125A and 126A can form a curved arch.

Faces 114A and 116A of panel 110A are typically planer and are typicallydisposed in parallel alignment. In one embodiment panel 110A has amaximum thickness extending between faces 114A and 116A in a rangebetween about 1 cm and 6 cm. Other thicknesses can also be used. Ifdesired, exterior face 116A can be contoured and/or sloped relative tointerior face 114A. Interior face 114A, however, is typicallysmooth/planar to achieve full contact with condenser bag 102 withoutrisk of damage to condenser bag 102.

Second panel 110B has substantially the same configuration and samecomponents as first panel 110A but is the mirror image in design. Likeelements between panels 110A and B are identified by like referencecharacters except that the elements of first panel 110A include theletter “A” while element of second panel 110B include the letter “B”. Asdepicted in FIG. 7 , second panel 110B comprises an outer cover 220B andan inner panel 222B. Outer cover 220B has an inside face 224B andopposing exterior face 116B with perimeter edge 123B extendingtherebetween. A recessed pocket 226B is formed on inside face 224B thatis complementary to and configured to receive inner panel 222B. In oneembodiment, outer cover 220B is made from a polymeric material, such asa polyurethane foam, that can be over molded onto inner panel 222B.Otherwise, it can be attached by an adhesive or other fasteningtechnique.

In general, inner panel 222B has interior face 114B and an opposingexterior face 231B with a perimeter edge 236B extending therebetween.Perimeter edge 236B has a configuration complementary to perimeter edge123A except that it has a slightly reduced dimension so that it cansnugly fit within recessed pocket 226B. Inner panel 222B bounds a fluidchannel 128B. More specifically, inner panel 222B comprises a panel body228B, a cover plate 230B and seal 232B that is disposed therebetween.Panel body 228B has interior face 114B and an opposing outer face 234B.Recessed within outer face 234B is fluid channel 128B.

As more clearly depicted in FIG. 8 , fluid channel 128A of first panel110A, which has the same configuration as fluid channel 128B of secondpanel 110B, lies beneath at least 60% and more commonly at least 70%,80% or 90% of interior face 114A (FIG. 6 ). Fluid channel 128A starts atan inlet port 130A that communicates through a bottom edge of innerpanel 222A and terminates at an outlet port 132A that communicatesthrough the bottom edge of inner panel 222A. In alternative embodiments,ports 130A and 132A can be disposed at different locations on innerpanel 222A. Furthermore, fluid channel 128A is shown having, in part, asinusoidal or tortious path but can have a variety of differentconfigurations. By traveling in a tortious path, the fluid travelingthrough fluid channel 128A is retained within inner panel 222A/firstpanel 110A for an extended period, thereby optimizing heat transferbetween the fluid traveling through fluid channel 128A and inner panel222A. A vent port 134A extends through the top edge of inner panel 222Aand communicates with fluid channel 128A. Vent port 134A is used forremoving air from fluid channel 128A when filling fluid channel 128Awith liquid and can be plugged during use by any conventional form ofplug.

Returning to FIG. 7 , cover plate 230B is secured on outer face 234B ofpanel body 228B with seal 232B positioned therebetween so as to sealfluid channel 128B closed except for access through ports 130B, 132B and134B. Cover plate 230B can be secured by use of screws, welding, otherfasteners, or other conventional techniques.

Inner panel 222B, and particularly panel body 228B, is typicallycomprised of a material having high thermal conductivity to permit goodheat transfer between inner panel 222B and condenser bag 102. Preferredmaterials include metals such as aluminum, stainless steel, or the like.Other materials having a relatively high thermal conductivity can alsobe used. Cover plate 230B acts as an insulator for inner panel 222B andis typically made of a material having a lower thermal conductivity thaninner panel 222B or panel body 228B. For example, as previouslymentioned, cover plate 230B is typically made of polymeric material orpolymeric foam, such as polyurethane foam. Again, other materials canalso be used.

It is again noted that panels 110A and 110B have substantially the sameconfiguration and the same components but are the mirror image indesign. As such, discussions herein with regard to one of panels 110A or110B are equally applicable to the other panel 110A or 110B.

Panels 110A and B are hingedly coupled together by bracket 140.Specifically, bracket 140 includes a back 142 having a first side 143and an opposing second side 144 that extend between an upper end 145 anda lower end 146. First side 143 is connected to exterior face 116B ofsecond panel 110B by a pair of spaced apart hinges 147A and 147B thatare disposed adjacent to inside edge 118B. Second side 144 is rigidlysecured to first panel 110A at exterior face 116A. As a result of thisconfiguration, panels 110A and 110B can be selectively moved between aclosed position, as shown in FIG. 5 , where panels 110A and B aredisposed in substantially parallel alignment, and an open position, asshown in FIG. 6 , wherein second panel 110B is outwardly rotatedrelative to first panel 110A so that panels 110A and B are disposed indiverging planes. In alternative embodiments, it is appreciated thathinges 147A and B can be mounted on first panel 110A instead of or inaddition to being mounted on second panel 110B. Furthermore, in analternative embodiment, instead of being mounted on exterior face 116Aand/or 116B, hinges 147A and B can be mounted on inside edges 118Aand/or 118B. A variety of other hinge configurations and types can alsobe used.

Back 142 of bracket 140 is sized so that when panels 110A and B are inthe closed position, a gap 148 is formed between interior faces 114A andB of panels 110A and B adjacent to inside edges 118A and B. Gap 148 canbe a variety of different thickness depending on factors such as the gasflow rate and the temperature of condenser 100. In some commonembodiments, gap 148 is typically in a range between about 0.5 cm and 3cm with about 1 cm to about 2 cm being more common. Other dimensions canalso be used. As discussed below in more detail, gap 148 can be used toregulate the gas flow rate through condenser bag 102.

Returning to FIG. 7 , bracket 140 also includes an arm 150 outwardlyprojecting from upper end 145 of back 142. Arm 150 terminates at aU-shaped catch 152 that is positioned vertically over container 12within support housing 14. Catch 152 is used to capture and retainexhaust port 92 on container 12 (FIG. 2 ). Attached to and horizontallyextending from arm 150 is a mount 154. As depicted in FIGS. 5 and 9 ,mount 154 is used, in part, for securing condenser 100 to supporthousing 14. Specifically, fasteners 155A and B, that are secured to lip32 of support housing 14, are used to releasably attach mount 154 tosupport housing 14 through holes formed on mount 154. It is appreciatedthat any number of different types of fasteners can be used to securemount 154 to support housing 14. In alternative embodiments, mount 154can be formed as an integral, unitary part of bracket 140, as opposed tobeing attached thereto, or can be separately attached to one or both ofpanels 110A and B, either through hinges or rigid fasteners. Othertechniques can also be used to secure condenser 100 to support housing14.

Mount 154 is typically positioned at a location between and spaced apartfrom top edges 122 and bottom edge 124 of panels 110 so that a portionof condenser 100 projects above lip 32 of support housing 14 andcontainer 12 and a portion projects below lip 32 of support housing 14when condenser 100 is mounted to support housing 14. For example, topedge 122A is typically at least 5 cm and more commonly at least 10 cmabove lip 32 of support housing 14 while bottom edge 124A is typicallyat least 5 cm and more commonly at least 10 cm below lip 32 of supporthousing 14. This positioning helps to optimize both access to andoperation of condenser bag 102 which is received within condenser 100.However, other positions can also be used. In the attached position,panels 110 are typically vertically orientated and radially outwardlyproject from the exterior surface of support housing 14. If desired,panels 110 could also be angled, such as in a range between +/−10° or20° relative to vertical.

Returning to FIG. 6 , mounted on outside edge 120A of first panel 110Aare a plurality of spaced apart latches 240 while mounted on outsideedge 120B of second panel 110B are a plurality of catches 242. Whenpanels 110A and B are in the closed position, latches 240 can engagecatches 242 so as to securely lock panels 110A and B in the closedposition. Latches 240 are configured so that gap 148 is also formedbetween panels 110A and B adjacent to outside edges 120A and B whenpanel 110 are in the closed position. It is appreciated that any numberof different types of latches can be used to securely lock panels 110Aand B together in the closed position. Examples of other types oflatches include Velcro (hook and eye) straps, buckles, ties, clamps,bolts, threaded fasteners, and the like.

In one embodiment of the present invention, means are provided forlocking panels 110A and B together in the closed position so that gap148 between panels 110A and B can be adjusted. One example of such meanscan include mounting a second catch 242A on outside edge 120B of secondpanel 110B on the near side and/or far side of each catch 242. As aresult, latches 240 can be used to engage catches 242 or 242A dependingon the desired width for gap 148. As discussed below in more detail,adjusting the width of gap 148 adjusts the flow rate at which gas passescondenser bag 102 that is held between panels 110A and B. In general,the gas flow rate decreases as the width of gap 148 increases. Thus, byhaving multiple different catches 242 and 242A, the width of gap 148 canbe set to optimize processing parameters. It is appreciated that thereare a wide variety of conventional locking techniques, such as Velcro(hook and eye) straps, buckles, ties, adjustable clamps, threadedfasteners, and other types of latches, and the like, that can be used toreleasably lock panels 110A and B in the closed position so as to permitadjusting gap 148 between panels 110A and B.

In one embodiment of the present invention, means are provided forregulating the temperature of condenser 100. By way of example and notby limitation, FIG. 1 depicts chiller 104 being fluid coupled tocondenser 100 by delivery lines 158A and 158B being coupled within inletports 130A and B (FIG. 6 ) and return lines 160A and 160B coupled withinoutlet ports 132A and B (FIG. 6 ), respectively. Chiller 104 cancomprise a conventional, off-the-shelf recirculating chiller that isconfigured to hold a volume of fluid (typically water), chill the fluidto a desired temperature, and then circulate the fluid into and out ofchiller body 205 through delivery lines 158 and return lines 160,respectively. One example of chiller 104 is the Neslab RTE-221recirculating chiller produced by Thermo Fisher Scientific. Otherconventional recirculating chillers will also work.

During operation, chiller 104 pumps a continuous stream of a fluidchilled to a desired temperature to inlet ports 130A and B of condenser100 through delivery lines 158A and 158B. The chilled fluid then flowsthrough fluid channels 128A and B within condenser 100 to outlet ports132A and B. Finally, the fluid passes out through outlet ports 132A andB and returns to chiller 104 through return line 160A and B. Because ofthe high thermal conductivity of the material of inner panels 222A and222B that bound fluid channels 128A and B, the cooled fluid absorbs heatfrom panels 110A and B and from objects contacting opposing interiorfaces 114A and B of panels 110. Chiller 104 is typically operated withthe fluid passing therethrough being cooled to a temperature in a rangebetween about 3° C. to about 18° C. with about 3° C. to about 10° C.being more common. Other temperatures can also be used.

Other means for regulating the temperature of condenser 100 can also beused. For example, the chiller can be designed to circulate a gas andcan be provided with a compressor that compresses and expands the gas sothat the chiller operates as a refrigeration system that cools condenser100. The chiller can also be designed to blow cooled air or other gasesthrough condenser 100. Other conventional chillers and systems forcooling can also be used for cooling condenser 100.

Turning to FIG. 10 , condenser bag 102 generally comprises a body 164having an intake port 166 disposed at one end and an exhaust port 168disposed at the opposing end. Body 164 comprises a flexible, collapsiblebag comprised of one or more sheets of polymeric film. Body 164 can becomprised of the same materials and produced using the samemanufacturing methods as previously discussed above with regard tocontainer 12. In the depicted embodiment, body 164 comprises a pillowtype bag that is manufactured from two overlapping sheets 170A and B ofpolymeric film that are seamed together around a perimeter edge 172.Body 164 has an interior surface 174 and an opposing exterior surface176. Interior surface 174 bounds a channel 178 that extends between afirst end 179 and an opposing second end 181. Formed at first end 179 isan inlet opening 184 where intake port 166 is attached while formed atsecond end 181 is an outlet opening 185 where exhaust port 168 isattached. Exterior surface 176 comprises first side face 180 and anopposing second side face 182.

With reference to FIG. 10 , body 164 can be defined in terms of specificparts that bound sections of channel 178. Specifically, body 164comprising a first leg 188 located at first end 179. First leg 188upwardly extends from a first end coupled with intake port 166 and anopposing second end coupled with a first arm 190. First leg 188 bound afirst channel section 189 that extends along the length thereof. Firstarm 190 laterally extends from first leg 188 to a first end of a secondleg 192. First arm 190 bounds a second channel section 191 extendingalong the length thereof. Second leg 192 downwardly projects from itsfirst end to a second end. Second leg 192 bounds a third channel section194 that extends along the length thereof. In the depicted design, leg188, arm 190, and leg 192 form a first section of body 164 having aU-shaped configuration, the channel sections extending therethrough alsocombine to form a U-shaped configuration.

Coupled to the second end of second leg 192 is the first end of a thirdleg 196. Third leg 196 upwardly projects to a second end in asubstantially vertical orientation. Exhaust port 168 is secured to thesecond end of third leg 196. Third leg 196 bounds a fourth channelsection 198 that extends along the length thereof. The combination oflegs 192 and 196 and the combination of channel sections 194 and 198each combine to form a second section having a U-shaped configuration.It is understood that all of the channel sections are coupled togetherso that gas entering through intake port 166 can sequentially passthrough channel sections 189, 191, 194, and 198 and then exit throughexhaust port 168. The U-shaped sections of body 164 increase theretention time of the gas therein to improve condensation. Body 164 isalso configured so that condensed liquid collects within the secondU-shaped section at a lower end 201 of body 164.

Although legs 188, 192 and 196 are shown as being linear and in parallelalignment, in alternative embodiments one or more of the legs can beangled, such as in a range between 1° to 45° relative to vertical, orextend in a curved or irregular path. Likewise, arm 190 can extendhorizontally to intersect perpendicular with leg 188 and/or leg 192.Alternatively, arm 190 can extend at an angle, such as in a rangebetween 1° to 45° relative to horizontal or in a curved or irregularpath. For example, arm 190 can extend in a curved arch between legs 188and 192.

In the depicted embodiment, a slot 200 is shown separating legs 192 and196 except where they are coupled together at lower end 201 of body 164.In alternative embodiments, legs 192 and 196 can be separated by apartition. In one embodiment, the partition can be produced by forming aweld seal between sheets 170A and B along the current location of slot200 so that fluid cannot pass through the partition. The weld seal isformed by welding together overlapping sheets 170A and B using methodsknown in the art such as heat energies, RF energies, sonics, or othersealing energies. In an alternative embodiment, the partition can beproduced by forming a linear ridge along interior face 114A and/or 114Bof condenser 100 (FIG. 6 ) so that when condenser bag 102 is closedbetween panels 110A and B, the one or both ridges pinch sheets 170A andB together so as to form a temporary seal along the current location ofslot 200. Other methods can also be used. If desired, legs 192 and 196can be spaced apart similar to legs 188 and 192 by forming a second armthe laterally extends between the second end of second leg 192 and thefirst end of third leg 196.

The channel sections bounded within the arms and legs of body 164 canalso extend in the same orientations as discussed above with regard tothe corresponding arms and legs. For example, if it is desired tomaintain gas longer within second leg 192 to improve condensation of thegas, second leg 192 can be formed so that third channel section 194downwardly extends in a sinusoidal path or other curved path.

Body 164 includes an extension 202 downwardly projecting from lower end201 of body 164 and bounds a collection pocket 204 that forms a portionof channel 178. More specifically, collection pocket 204 is formed atthe first end of third leg 196 so as to be in alignment with and influid communication with fourth channel section 198. A transfer line206, such as in the form of a flexible tube, has a first end 208 coupledwith extension 202 so as to be in fluid communication with collectionpocket 204 and has an opposing second end 210 coupled with first leg 188so as to be in fluid communication with first channel section 189.Although transfer line 206 typically comprises polymeric tubing, othermaterials and tube designs can be used. First end 208 of transfer line206 can couple with extension 202 through a port 214 mounted thereonwhile second end 210 of transfer line 206 can couple with first leg 188through a port 216 mounted thereon. As a result, fluid collected incollection pocket 204 can be pumped into first channel section 189. Asdiscussed below in more detail, by pumping the fluid into first channelsection 189, the fluid naturally falls under gravitational force downthrough intake port 166 of condenser bag 102 and through exhaust port 92of container 12 so as to be returned to compartment 50 of container 12.

As depicted in FIG. 11 , intake port 166 of condenser bag 102 comprisesa tubular stem 250 having an interior surface 251 and an opposingexterior surface 253 that extends between a first end and an opposingsecond end. The first end is secured to inlet opening 184 of body 164such as by being received within inlet opening 184 and being weldedthereto. Encircling and outwardly projecting from the second end of stem250 is a coupling flange 252. Coupling flange 252 has a top surface 254with an annular seal 256 formed thereon. (Seal 256 is shown on exhaustport 168 which has the same configuration as intake port 166).

Interior surface 251 bounds a port opening 257 that extends through stem250 and communicates with channel 178. In the depicted embodiment, portopening 257 has a circular transverse cross section. Otherconfigurations can also be used such as elliptical, polygonal, irregularor the like. The transverse cross section of port opening 257 typicallyhas a maximum diameter in a range between about 0.5 cm to about 15 cmwith about 2 cm to about 10 cm being more common. For high gasthroughput, the maximum diameter is typically greater than 3 cm, 4 cm, 5cm or 6 cm. Other dimension can also be used depending on the intendedapplication. The body of intake port 166 is typically molded from apolymeric material and is more rigid than body 164. Annular seal 256 istypically formed from an elastomeric material that is more flexible thanthe port body on which it is attached.

Coupling flange 252 of intake port 166 of condenser bag 102 isconfigured to mate with coupling flange 99 of exhaust port 92 oncontainer 12 so that when clamp 258 is tightened over the mated flanges99 and 252, seals 103 and 256 press together forming a gas tight sealthat will maintain sterility. In the depicted embodiment, flanges 99 and252 have the same size and configuration. Furthermore, aligned portopenings 97 and 257 have the same size and configuration so that thereis no restriction of the gas as it passes between the ports. However, itis not necessary that the ports have the same size port opening as longas a sterile connection can be made between the ports. It is noted thatexhaust port 92 on container 12 and intake port 166 of condenser bag 102are typically coupled together by clamp 258 at the end of themanufacturing stage so that container 12 and condenser bag 102 can beconcurrently sterilized, such as by radiation, prior to shipping anduse. In contrast to using flanges and a clamp to secure ports 92 and 166together, it is appreciated that a variety of other types of mechanicalconnections can be used such threaded connections, snap-fit connections,bayonet connections, sterile connectors and other types of connectorsthat can maintain a sterile connection. These types of alternativeconnections are also applicable to the other port coupling discussedherein where flanges and a clamp is used to form the connection.

Exhaust port 168 can have the same configuration, dimensions,composition and properties as intake port 166 and can be secured tooutlet opening 185 at second end 181 of body 164 using the same methodas discussed with intake port 166. Accordingly, like elements betweenports 166 and 168 are identified by like reference characters.

Condenser bag 102 serves two primary functions. First, humid gas exitingout of container 12 is cooled within condenser bag 102 by condenser 100so that the vapor condenses into a liquid and is collected withincollection pocket 204. The liquid is then subsequently removed. Asdiscussed below, dehumidifying the gas prevents clogging of downstreamfilters. Second, as a result of adding gas into container 12 throughsparger 54 (FIG. 2 ), foam can be produced at the upper end of container12. The foam can potentially enter and travel along condenser bag 102.However, if the foam reaches the downstream filters, the foam can clogthe filters. Condenser bag 102 is thus formed having channel 178 with asufficient length so that the humid gas is retained therein for asufficient time to achieve the desired condensation and to break downany foam entering channel 178 before it exits condenser bag 102. Toachieve the desired retention time, it is appreciated that channel 178can have a variety of different lengths and configurations.

In addition to channel 178 have a variety of different configurations,transfer line 206 can be connected at a variety of different locations.For example, with reference to FIG. 10 , collection pocket 204 could beformed at any location along lower end 201 of body 164, such as inalignment with second leg 192 or at the junction between legs 192 and196, were water will collect. Collection pocket 204 can also beeliminated and transfer line 206 can be positioned at any locationaligned with second leg 192, third leg 196 or at the junction betweenlegs 192 and 196 where water will collect. Furthermore, second end 210of transfer line 206 need not connect with first leg 188 or first end179 of body 164 but can be directly coupled with intake port 166. Forillustration, depicted in FIG. 12 is an alternative embodiment of acondenser bag 102A wherein like elements between condenser bag 102 and102A are identified by like reference characters. Condenser bag 102Aincludes a body 164A that includes legs 192 and 196. Legs 192 and 196join at U-shaped junction 212 where the condensed liquid collects. Firstend 208 of transfer line 206 is coupled with body 164A at junction 212.Second end 210 of transfer line 206 is coupled directly with the side ofintake port 166 so that the liquid is dispensed into port opening 257which then falls down into container 12.

In another alternative embodiment, intake port 166 of condenser bag 102can be eliminated. For example, depicted in FIG. 13 is a condenser bag102B where like elements between condenser bag 102 and 102B areidentified by like reference characters. Condenser bag 102B includesbody 164 having exhaust port 168 mounted thereon. However, inlet opening184 is not coupled with intake port 166 (FIG. 10 ) but rather is nowcoupled directly with a modified exhaust port 92A. Like elements betweenexhaust port 92 on container 12 and exhaust port 92A are identified bylike reference characters. Exhaust port 92A includes stem 93 havingmounting flange 96 formed at the first end thereof for coupling withcontainer 12, as previously discussed, and includes retention flange 98with annular groove 108 formed between flanges 96 and 98. However,coupling flange 99 has been eliminated. The second end of stem 93 is nowelongated and configured to be received within inlet opening 184 of body164 so as to be welded and sealed directly thereto. As a result, theopposing ends of port 92A are secured directly to container 12 and body164, thereby eliminating the need for intake port 166 and clamp 258.

Returning to FIG. 5 , container 12 and condenser bag 102 are typicallypreassembled and sterilized during the manufacturing stage. During use,container 12 is positioned within support housing 14 while attachedcondenser bag 102 is mounted on condenser 100. Specifically, condenser100 is moved to the open position, as shown in FIG. 6 , following whichcondenser bag 102 is placed between panels 110A and B. Condenser bag 102is orientated so that arm 190 projects out from between panels 110A andB toward container 12 while exhaust port 168 is aligned with notches129. In this position, condenser 100 is moved to the closed position, asshown in FIG. 5 , and latches 240 are locked in place so that condenserbag 102 is captured between panels 110A and B. Because of gap 148,however, condenser bag 102 is not compressed between the interiorsurfaces of panels 110A and B prior to operation but rather is free toexpand slightly within gap 148 when gas is received therein. Extension202 of condenser bag 102 projects down below panels 110A and B so thatfirst end 208 of transfer line 206 is not compressed or potentiallykinked between panels 110A and B. In alternative designs, the lower endof body 164 could project below panels 110A and B or a slot, notch, orother opening could be formed on one of panels 110A and B to receivefirst end 208 of transfer line 206 so that no portion body 164 needs toextend below panels 110A and B. As depicted in FIG. 1 , transfer line206 is coupled with pump 106 so that fluid can be pumped along transferline 206. Pump 106 typically comprises a peristaltic pump but otherpumps could also be used depending on the application.

With reference to FIGS. 9 and 11 , exhaust port 92 on container 12 isattached to bracket 140 mounted on support housing 14. Specifically,exhaust port 92 is laterally slid onto catch 152 so that catch 152 isreceived within first annular grove 108 and retention flange 98 rests ontop of catch 152. In this configuration, exhaust port 92 is securelyheld in place with port opening 97 facing vertically upward. If desired,retention flange 98 can be angled so that exhaust port 92 projects at anangle. For example, exhaust port 92 can have a central longitudinal axisthat projects at an angle in a range between 0° and 30° and more commonbetween 0° and 15° relative to vertical. Once condenser bag 102 isattached to condenser 100 and coupled with container 12, an upper end199 (FIG. 10 ) of condenser bag 102 can be positioned above andvertically over container 12 while lower end 201 (FIG. 10 ) of condenserbag 102 can be positioned radially outside of support housing 14 at alocation below lip 32 of support housing 14. Although condenser bag 102can also be in other positions, this position helps to optimize accessto condenser bag 102 and coupling with container 12. This configurationalso optimizes use of condenser system 16 in rooms with low ceilingheights.

Once container 12 and condenser bag 102 are properly positioned, driveshaft 72 of mixer system 18 is coupled with impeller assembly 78 aspreviously discussed. A fluid solution and any desired components arethen fed through various ports into container 12. With reference to FIG.2 , while mixer system 18 mixes the contents within container 12,sparger 54 is used to deliver a gas, such as oxygen and/or other gases,into the solution at the lower end of container 12. As the gas passesthrough the solution, a portion of the gas is absorbed into the solutionand gases such as carbon dioxide are desorbed from the solution. Theremaining gas that is not absorbed by the fluid increases in humidity asa result of the solution to form a humid gas that passes into a headspace 162 at the upper end of container 12. As previously discussed, thegas also typically forms foam that is collected in head space 162.

With reference to FIG. 9 , as the gas pressure increases withincontainer 12, the humid gas passes out through exhaust port 92 ofcontainer 12 and into channel 178 of condenser bag 102 through intakeport 166. The humid gas causes condenser bag 102 to inflate. Leg 188 ofcondenser bag 102 is positioned outside of condenser 100 and can thusfreely inflate. Condenser bag 102 is typically positioned so that whenleg 188 is inflated, leg 188 and the channel section therein arelongitudinally aligned with port opening 97 of exhaust port 92 (FIG. 11). Thus, where the central longitudinal axis of exhaust port 92 isvertically aligned or offset by and angle relative to vertical, leg 188and the channel section therein are also typically aligned vertically orare offset by the corresponding angle so as to be aligned.

The portion of condenser bag within condenser 100 expands so that theopposing sides of condenser bag 102 push directly against interior faces114A and 114B of inner panels 222A and 222B (FIG. 6 ). Chiller 104 isactivated at the start of the process so that inner panels 222A and 222Bare cooled by the chilled fluid passing therethrough. As such, the humidgas passing through condenser bag 102 is cooled by thermal energy beingabsorbed by inner panels 222A and 222B. As the humid gas is cooled, themoisture within the humid gas begins to condense so as to form acondensed liquid and a dehumidified gas. As discussed below, thedehumidified gas passes into filter system 17. The condensed liquidflows downward under gravity to lower end 201 of condenser bag 102 andinto collection pocket 204 (FIG. 10 ).

Through the use of pump 106, the condensed liquid flows out of channel178 through tubular port 214, travels along transfer line 206 and thendispenses back into first leg 188 or into intake port 166, depending onthe embodiment. As previously discussed, because first leg 188 andintake port 166 are aligned either vertically or at some vertical anglewith exhaust port 92 on container 12, the condensed fluid freely flowsunder the force of gravity back into compartment 50 of container 12. Inalternative embodiments, it is appreciated that the second end oftransfer line 206 could be coupled to a port coupled directly tocontainer 12 or could be coupled to a separate container for collectionof the condensed liquid. However, by having transfer line 206 connectback onto body 164, container 12 and condenser bag 102 can be completelymanufactured at separate facilities or at different locations followingwhich only a single connection is required to couple container 12 andcondenser bag 102 together. As a result, the inventive condenser bagsimplifies the manufacturing process and reduces manufacturing costs.

Condenser system 17 also has a number of other advantages overtraditional condensers. For example, exhaust port 92 of container 12 andintake port 166 and exhaust port 168 of condenser bag 102 can be formedwith large diameter port openings, as discussed herein. These largediameters enable large flow rates of gas to be easily and efficientlyprocessed. For example, the inventive system, depending on the sizethereof, can commonly operate at gas flow rates greater than 200 or 600standard liters per minute (“slpm”) and depending on the size thereof,it is envisioned that it can operate at gas flow rates greater than2000, 5,000 or 10,000 slpm. Of course, the system can also operate atlower flow rates. Expressed in other terms, some embodiments of thesystem commonly operate at a gas flow rate between about 0.5 to about2.5 vessel volumes per minute (based on the volume of container 12) withabout 1 to about 2 vessel volumes per minute being more common.

Furthermore, in contrast to prior art condensers where the condenser bagis remotely coupled to the reactor bag by tubing, in one embodiment ofthe present invention the condenser bag 102 is directly coupled tocontainer 12. This configuration occupies less space and simplifies thedesign and operation of the system while reducing material andmanufacturing costs. Furthermore, because condenser 100 and condenserbag 102 can be configured to downwardly project along the length ofsupport housing 14, as opposed to only projecting up above container 12,condenser system 16 is particularly useful in areas where there are lowceiling height restrictions.

An additional benefit of one embodiment of the inventive system is thatthe gas flow rate within condenser bag 102 can be easily adjusted. Forexample, if higher gas output is required without increasing gaspressure, gap 148 between the condenser panels 110 be incrementallywidened. This will permit condenser bag 102 to further expand so that agreater flow rate of gas can pass therethrough without increasing gaspressure.

Condenser bag 102 is also beneficial in that it is relativelyinexpensive to manufacture, is easy to ship and install, and isdisposable, thereby requiring no sterilization between uses. Otherbenefits also exist.

Depicted in FIG. 12A is another alternative embodiment of a condenserbag 102B wherein like elements between condenser bags 102, 102A and 102Bare identified by like reference characters. Condenser bag 102Bcomprises a bag body 164A that includes overlapping sheets 170A and 170Bthat are welded or otherwise secured together around their perimeteredge to form a pillow bag. Body 164A bounds a channel 178 extendingbetween opposing ends 179 and 181 and includes arm 190 and legs 192 and196 which join together at U-shaped junction 212. Legs 192 and 196 areseparated along a portion of their length by a partition 203. Partition203 is formed by a weld seal that welds sheets 170A and 170B together.

In contrast to body 164A (FIG. 12 ), in body 164B first leg 188 has beeneliminated. Intake port 166 is now secured to the face of sheet 170A atan inlet opening at first end 179 and exhaust port 168 is secured to theface of sheet 170B at an outlet opening at second end 181. During use,condenser 100 is mounted to support housing 14 so that condenser 100 iseither horizontally disposed, i.e., rotated 90° relative to the verticalorientation depicted in FIG. 9 , or is orientated at an angle in a rangebetween 5° and 45° relative to the horizontal or more commonly at anangle in a range between 10° and 30° relative to horizontal. In thisposition, condenser bag 102B is positioned between panels 110A and 110Bso that U-shaped junction 212 is at the low point.

Intake port 166 is the coupled with exhaust port 92 of container 12 sothat gas from container 12 flows into condenser bag 102B. When condenserbag 102B is sloped, the condensed fluid collects at U-shaped junction212 against sheet 170A. Transfer line 206 has first end 208 fluidcoupled to the face of sheet 170A at U-shaped junction 212 and opposingsecond end 210 either coupled to the face of sheet 170B at first end179, directly above intake port 166, or is coupled to the side of intakeport 166. As a result, fluid collected within condenser bag 102B atU-shaped junction 212 can be pumped through transfer line 206 and thendispensed back into container 12 by passing through intake port 166 andexhaust port 92.

The above configuration and placement of condenser bag 102B has many ofthe same benefits as discussed above. In addition, it permits all ofcondenser bag 102 to be maintained at a higher elevation. Depending onthe application, this can have additional benefits such as in spacesavings and less energy required to pump the condensed liquid throughtransfer line 206.

As depicted in FIG. 14 , filter system 17 is coupled with exhaust port168 of condenser bag 102. Filter system 17 includes a filter assembly260 having a plurality of electrical heating jackets 262A-D mountedthereon. As depicted in FIG. 15 , filter assembly 260 comprises a casinghaving an intake port 266 mounted thereon and a plurality of exhaustports 268A-D mounted thereon. Casing 264 comprising a flexible,collapsible bag comprised of one or more sheets of polymeric materialsuch as polymeric film. Casing 264 can be comprised of the samematerials and be produced using the same manufacturing methods aspreviously discussed above with regard to container 12. In the depictedembodiment, casing 264 comprises a pillow type bag that is manufacturedfrom two overlapping sheets of polymeric film that are seamed togetheraround the perimeter edge.

Casing 264 has an interior surface 270 and an opposing exterior surface272. Interior surface 270 bounds a compartment 274. Casing 264 can bedefined in terms of specific parts that bound sections of compartment274. Specifically, casing 264 comprises a tubular inlet 276 having afirst end on which an inlet opening 267 is formed. Inlet opening 267 isconfigured to be coupled with intake port 266. Inlet 276 has an opposingsecond end that is coupled to a laterally extending tubular manifold278. Outwardly projecting from manifold 278 on the side opposite ofinlet 276 is a plurality of tubular sleeves 280A-D. Each sleeve 280A-Dhas a first end 282A-D fluid coupled with manifold 278 and an opposingsecond end 283A-D having a corresponding outlet opening 284A-D formedthereat. Each outlet opening 284A-D is configured to be coupled with acorresponding exhaust port 268A-D. Each inlet 276, manifold 278, andsleeve 280 bounds a portion of compartment 274 so that gas enteringthrough inlet opening 267 can travel through inlet 276, through manifold278, and through each sleeve 280A-D to outlet openings 284A-D.

In the embodiment depicted, sleeves 280A-D are disposed in parallelalignment and are orthogonal to manifold 278. In alternativeembodiments, sleeves 280A-D need not be in parallel alignment and can beangled relative to manifold 278. However, there are operational benefitsto using the depicted design. Inlet 276 is depicted as being alignedwith sleeve 280B but can be positioned on manifold 278 so as to beoffset from sleeves 280. Furthermore, in alternative embodiments inlet276 can be eliminated by having inlet opening 267 and intake port 266disposed directly on manifold 278.

Intake port 266 can have the same configuration, dimensions, compositionand properties as previously discussed with regard to intake port 166 offilter bag 102. As such, like elements between intake port 166 andintake port 266 are identified by like reference characters. Intake port266 is typically secured to casing 264 using the same method that intakeport 166 of filter bag 102 is secured to body 164. For example, stem 250of intake port 266 can be secured to inlet 276 by being received withininlet opening 267 and welded to inlet 276 so that coupling flange 252 isopenly exposed. During use, intake port 266 of filter assembly 260 iscoupled with exhaust port 168 of condenser bag 102 in the same way thatintake port 166 of condenser bag 102 is coupled with exhaust port 92 oncontainer 12, as previously discussed. That is, the coupling flanges ofintake port 266 and exhaust port 168 are clamped together using a clamp273 so that the aligned seals 256 press together forming a gas tightseal that will maintain sterility. Again, the aligned port openings 257of the ports typically have the same size and configuration so thatthere is no restriction of the gas as it passes between the ports.However, it is not necessary that the ports have the same size portopening as long as a sterile connection can be maintained between them.

As depicted in FIG. 16 , each exhaust port 268 comprises a tubular stem294 having an interior surface 296 and an opposing exterior surface 298extending between a first end 300 and an opposing second end 302. Formedon interior surface 296 at first end 300 is a connector. In the depictedembodiment, the connector comprises a pair of opposing bayonet slots 304formed on first end 300 so as to form half of a bayonet connection.Interior surface 296 bounds a port opening 303 which can have the sameconfigurations and dimensions as previously discussed with regard toport opening 257 of inlet port 166. Encircling and radially outwardlyprojecting from second end 302 of stem 294 is a flange 306. Duringattachment, first end 300 of stem 294 of each exhaust port 268A-D can bereceived within the corresponding outlet opening 284A-D and welded tocorresponding sleeve 280A-D so that flanges 306 are openly exposed.

Returning to FIG. 15 , disposed within each sleeve 280A-D of casing 264is a corresponding filter 280A-D that is coupled with a correspondingexhaust port 268A-D. As depicted in FIGS. 16 and 17 , filter 290Acomprises a filter body 310 having an interior surface 312 and anexterior surface 314 extending between a first end 316 and an opposingsecond end 318. Filter body 310 includes a tubular side wall 320 thatextends between opposing ends 316 and 318 and a floor 322 disposed atsecond end 318. As such, interior surface 312 bounds a blind channel 324that centrally extends along the length of filter body 310 but which isblocked at second end 318 by floor 322. Upwardly projecting from firstend 316 of filter body 310 is a tubular neck 326. A pair of annulargrooves 328A and B encircle the exterior surface of neck 326 and areconfigured to receive corresponding annular seals 330A and B. Alsooutwardly projecting from the exterior surface of neck 326 at a locationbelow grooves 328A and B are a pair of opposing bayonet prongs 332. Anopening 334 extends through neck 326 and communicates with channel 324.

In one embodiment, filter body 310 is made of a porous material throughwhich gas can pass but through which unwanted contaminants, such asbacteria and microorganisms, cannot. The porous material is typicallyhydrophobic which helps it to repel liquids. For example, filter body310 can be comprised of polyvinylidene fluoride (PVDF). Other materialscan also be used. Where the system is acting as a bioreactor orfermentor, filter body 310 typically needs to operate as a sterilizingfilter and will thus typically have a pore size of 0.22 micometers (μm)or smaller. The term “pore size” is defined as the largest pore in thematerial through which a particle can pass. Commonly, filter body 310has a pore size in a range between 0.22 and 0.18 μm. However, forpre-filtering applications or for non-sterile applications, filter body310 can have a larger pore size, such as in a range between about 0.3and 1.0 μm. In still other applications, the pore size can be greaterthan 1.0 μm or smaller than 1.0 μm. One example of filter body 310 isthe DURAPORE 0.22 μm hydrophobic cartridge filter produced by Millipore.Another example is the PUREFLO UE cartridge filter available fromZenPure.

During assembly, seals 330 are received within annular grooves 328following which neck 326 of filter 290A is coupled to exhaust port 268by bayonet prongs 332 being received and rotated within bayonet slots304. In this configuration, filter 290A is securely attached to exhaustport 268A with seals 330 forming a gas tight seal between neck 326 andinterior surface 296 of exhaust port 268A. Next, filter 290A is slidwithin sleeve 280A of casing 264 so that exhaust port 268A is partiallyreceived within sleeve 280A. A gas tight seal is then formed betweensleeve 280A and exhaust port 268A such as by welding sleeve 280A toexterior surface 298 of stem 294. Filters 290B-D have the sameconfiguration as filter 290A and the same process can be used forattaching filters 290B-D to exhaust ports 268B-D and then securingfilters 290B-D within sleeves 280B-D of casing 264. During use, asdiscussed below in more detail, gas from condenser bag 102 enters filterassembly 260 from intake port 266 but can only exit filter assembly 260by passing through a corresponding filter body 310, traveling alongchannel 324 and then exiting out through a corresponding exhaust port268A-D. As such, filters 290 sterilize or otherwise filter all gaspassing out of filter assembly 260. Likewise, the only way gas and othermatter from the outside environment can enter filter assembly 260 isthrough filters 290. As such, filters 290 also function as sterilizingfilters that prevent outside contaminates from accessing the compartmentof filter assembly 260 which could then potentially contact the fluidwithin container 12.

Filter assembly 260 is designed to be capable of filtering high flowrates of gas. Specifically, as gas enters filter assembly 260, flexiblecasing 264 expands to the configuration shown in FIGS. 15 and 17 . Inthe expanded configuration, each sleeve 280 is spaced apart fromexterior surface 314 of each corresponding filter body 310 along thelength of filter body 310. As such, the gas can freely access and passthrough filter body 310 from all sides and along the full length offilter body 310, thereby optimizing the use of filter body 310 andmaximizing the gas flow rate therethrough. In one embodiment, theannular gap distance D between exterior surface 314 of filter body 310and the interior surface of the corresponding sleeve 280 is in a rangebetween about 0.15 cm to about 3 cm with about 0.2 cm to about 1 cmbeing more common. In some embodiments, the gap distance D can begreater than 1 cm or 2 cm. Other dimensions can also be used. In oneembodiment filter body 310 has a maximum transverse diameter in a rangebetween about 5 cm and about 10 Other dimensions can also be used.Furthermore, gap distance D typically extends over at least 80% and morecommonly at least 90%, 95% or 100% of the length of filter body 310.Filter assembly 260 can also process a high gas flow rate because theport openings of intake port 266 and exhaust port 268 can be designedhaving a surprising large diameter, such as greater than 3 cm, 4 cm, 5cm or 6 cm, and because filter assembly 260 can be designed tosimultaneous operate with a plurality of filters 290 that are disposedin parallel communication with the gas flow.

In an alternative embodiment, the filter and exhaust port can be formedas a single piece. For example, depicted in FIG. 17A is a filter 460.Like elements between filter 460 and previously discussed filter 290 areidentified by like reference characters. Filter 460 includes filter body310 which has the same structure, composition and properties aspreviously discussed. However, rather than including neck 326 at firstend 316, filter 460 includes an exhaust port 462 that is permanentlyfixed to first end 316 of filter body 310 such as by over molding,adhesive, welding, or the like. As such, no separate seal is neededbetween exhaust port 462 and filter body 310. Exhaust port 462 includesa stem 464 having an interior surface 466 and an opposing exteriorsurface 466 that extend between a first end 470 and an opposing secondend 472. Second end 472 is secured to filter body 310 as discussedabove. Encircling and outwardly projecting from first end 470 is aflange 474. Interior surface 466 bounds a port opening 476 that extendstherethrough and communicates with channel 324 of filter body 310.Filter body 310 is received within sleeve 280A and exterior surface 466of exhaust port 462 is received within outlet opening 284A of sleeve280A. Exterior surface 466 is sealed to sleeve 280A, such as by welding,so as to form a gas tight seal. Exhaust port 462 is typically comprisedof a non-porous polymeric material while filter body 310 is comprised ofa porous material, as previously discussed. In another embodiment, it isenvisioned that exhaust port 462 could be eliminated and that sleeve280A could be welded or otherwise secured directly to first end 316 offilter body 310.

Continuing with FIG. 16 , as will be discussed below in greater detail,to assist in integrity testing of filters 290 following use, disposed atfirst end 282 of each sleeve 280 or on manifold 278 adjacent to firstend 282 is a port 350 that communicates with compartment 274. A fillline 352, such as a flexible tube, has a first end 354 connected to port350 and an opposing second end 356 having a connector 358 securedthereto. Connector 358 can be a lure lock connector or any other type ofconnector which can connect to a gas source for delivering a gas throughfill line 352 to compartment 274. A clamp 360, such as a tube clamp, isdisposed on fill line 352. Clamp 360 seals fill line 352 closed prior touse so that contaminates cannot enter compartment 274 through fill line352. To eliminate clamps 360, connector 358 can be a type of connectorthat is sealed closed prior to use. For example, a sterile connector canbe used.

In some embodiments, the distance between intake port 266 and eachfilter 290, measured along the path at which the gas flows, is at least4 cm and more commonly at least 8 cm, 12 cm or 16 cm. Other dimensionscan also be used. This spacing adds minimal cost because it is formed bycasing 264 and adds the benefit of increasing filter life because thereis more space for liquid to condense from the gas before it reachesfilters 290. The spacing also provides area for seaming casing 264closed for the purpose of integrity testing, as discussed below.

As also depicted in FIG. 16 , each heating jacket 262 includes aninsulation pad 340 that can be wrapped into a cylindrical loop and heldin the desired configuration by straps 342 that encircle the exterior ofpad 340. Disposed either within pad 340 or on the interior surfacethereof is electrical heating tape 344. A hanger 346 can also projectfrom the upper end of pad 340 by connecting to either pad 340 or straps342. During use, each heating jacket 262 is wrapped around acorresponding sleeve 280. Jackets 262, however, are sized so thatsleeves 280 can still inflate to provide the desired gap between filters290 and sleeves 280 but are also typically configured so that sleeves280 push against the interior surface of heating jackets 262 to producean efficient heat transfer therebetween. Moisture that passes out ofcondenser bag 102 and into filter assembly 260 will collect on filters290 and eventually clog the filters. By activating heat tape 344,heating jackets 262 assist to heat and vaporize the condensed liquid onfilters 290 so that it can pass through and out of filters 290, therebyprolonging the active life of filters 290.

As depicted in FIG. 14 , filter system 17 is supported by a rackassembly 386. Rack assembly 386 includes a pole 388 having a first end390 and an opposing second end 392. First end 390 is slidably receivedwithin a retainer 394 that is secured on mount 154. Retainer 394 isconfigured to permit pole 388 to be raised and lowered to a desiredposition relative to condenser 100 and then releasably lock pole 388 inplace when it is at its desired position. In the depicted embodiment,retainer 394 comprises a clamp having a body 395 secured on mount 154with a passage extending therethrough in which pole 388 is slidablyreceived. A cam arm 396 is rotatably mounted on body 395 and isconfigured to press against pole 388 within the opening. Clamp arm 396moves between a raised first position where pole 388 can be raised andlowered and a lowered second position, as depicted, where clamp arm 396cams against pole 388 to lock it in place. It is appreciated thatretainer 394 can comprise a variety of other types of clamps orretainers to adjustably secure pole 388.

Mounted on second end 392 of pole 388 is a rack 398. Rack 398 includes aframe 400 having a first end mounted to pole 388 and an opposing secondend having a plurality of spaced apart catches 402A-D formed thereat.Each catch 402 has a U-shaped slot 403 formed thereon. Slots 403 areconfigured so that second end 302 of stem 269 (FIG. 16 ) of each exhaustport 268 can be snugly received within a corresponding slot 403 so thatflange 306 is supported on the top surface of each catch 402. As aresult, exhaust ports 268 are securely retained on rack 398. Withexhaust ports 268 secured to rack 398 while intake port 266 is securedto exhaust port 168 of condenser bag 102, raising and lowering pole 388enables filter assembly 260 to be expanded to its desired height so thatwhen gas is passed therethrough, casing 264 is inflated to its desiredconfiguration. For example, if casing 264 is not fully expanded by rackassembly 386, casing 264 can buckle when inflated and push againstfilters 290, thereby decreasing filter performance.

In the above assembled configuration, filter assembly 260 is disposedvertically above and in alignment with condenser bag 102 and isotherwise configured so that any liquid that condenses within casing 264can naturally flow under the force of gravity from filter assembly 260and into condenser bag 102 by passing through intake port 266 andexhaust port 168. Removing condensed liquid from filter assembly 260helps to preserve the operating life of filters 290. In one embodiment,during use exhaust port 168 of condenser bag 102, which is coupled withfilter assembly 260, can have a central longitudinal axis that projectsvertically or projects at an angle in a range between 0° and 20° andmore common between 0° and 10° relative to vertical.

As depicted in FIG. 14A, a tie rod 406 can be secured on the bottom sideof frame 400 so as to extend adjacent to each catch 402. Hangers 346 ofeach heating jacket 262 can be secured to tie rod 406. As a result, theweight of each heating jacket 262 is primary supported by rack 398 asopposed to casing 264. Furthermore, the use of tie rod 406 ensures thatheating jackets 262 are always properly positioned relative to casing264. It is appreciated that heating jackets 262 can be secured to rack398 using a variety of other techniques and structures.

During assembly, intake port 166 of condenser bag 102 is coupled withexhaust port 92 on container 12 while intake port 266 of filter assembly260 is coupled with exhaust port 168 of condenser bag 102, as previouslydiscussed. The connected container 12, condenser bag 102 and filterassembly 260 can then be concurrently sterilized, such as by radiation,so that the compartments therein are sterilized. The assembled systemcan then be shipped for use. During use, container 12 is received withinsupport housing 14, condenser bag 102 is secured to condenser 100, andfilter assembly 260 is mounted on rack assembly 386 and adjusted, aspreviously discussed. In this assembled state, the sparged gas fromcontainer 12 passes into condenser bag 102. The dehumidified gas fromcondenser bag 102 then passes into filter assembly 260 where it exitsout to the environment through filters 290.

Filter assembly 260, used either independently or in conjunction withcontainer 12 and/or condenser bag 102, has a number of unique benefits.For example, because casing 264 of filter assembly 260 is made frompolymeric film, as opposed to being a metal container or rigid plastichousing, filter assembly 260 is relatively simple and inexpensive toproduce. As such, filter assembly 260 is a single use item that can bedisposed of or recycled after a single use, thereby avoiding any needfor cleaning or sterilization.

Because container 12, condenser bag 102 and filter assembly 260 are eachcomprised of a polymeric film which is used to contain the gas beingexhausted, fluid processing system 10 is typically designed to operateat a relatively low gas pressure. That is, processing system 10 istypically configured so that during operation container 12, condenserbag 102 and/or filter assembly 260 operate at an internal gas pressureof under 10 kPa and typically in a range between about 0 kPa to about 8kPa with about 2 kPa to about 5 kPa being more preferred. Furthermore,container 12, condenser bag 102 and/or filter assembly 260 can bedesigned to fail by rupture of the polymeric film or seams formed on thepolymeric film when they are subject to an internal gas pressure of 50kPa or more commonly 60 kPa or 70 kPa.

To optimize operation at low gas pressures, processing system 10 can bedesigned so that the only back pressure produced in the gas flow pathextending from container 12 through filter assembly 260 is caused by thegas passing through filter(s) 290. For example, some traditionalbioreactor systems include a rigid reactor container, a rigid condensersystem and a rigid filter system through which the gas passes. Theserigid components are designed so that they can safely operate atrelatively high gas pressures, such as around 500 kPa. The traditionalrigid components are typically fitted with small diameter gas inletports and gas outlet ports, i.e., circular ports having a maximum insidediameter that is commonly less than 2 cm. When high gas flow rates areprocessed through these conventional systems, each of the gas intakeports and exhaust ports forms a gas restriction point that causes backpressure. Traditional systems use small diameter ports because theamount of back pressure produced is minimal relative to the pressurethat can be safely handled by the rigid components and because smalldiameter ports are less expensive and more standard in the industry. Inone embodiment of the present invention, however, each of the gas intakeports and the gas exhaust ports for container 12, condenser bag 102 andfilter assembly 260 are formed having a diameter or area that issufficiently large so that no back pressure is produced as the gaspasses therethrough. For low gas flow rates, such ports can berelatively small. For high gas flow rates, however, such as, forexample, flow rates greater than 300 slpm or 500 slpm, the gas intakeports and the gas exhaust ports for each of container 12, condenser bag102 and filter assembly 260 can be formed having a maximum insidediameter that is greater than 3 cm and more commonly greater than 4 cm,5 cm, 6 cm or 10 cm. The use of such sized ports is unique in the fieldof bioreactors and fermenters. It is understood that the larger portscan be used at lower gas flow rates or that smaller ports can be used atlower gas flow rates.

An additional benefit to using large diameter ports through which thegas passes is that the ports minimize the speed at which the gas passesthrough the ports. As previously mentioned, one of the intended benefitsof one embodiment of the present invention is that if any moisture fromthe gas condenses within filter assembly 260, the condensed liquid isfree to flow under the force of gravity down through intake port 266 andinto condenser bag 102. However, if exhaust port 168 or intake port 266are too small, the velocity of the gas passing therethrough can besubstantially increased. The high velocity gas can both precludecondensed liquid from flowing under gravity from filter assembly 260into condenser bag 102 and can force liquid that has condensed withincondenser bag 102 adjacent to intake port 266 to flow into filterassembly 260. Fluid collecting within filter assembly 260 can eventuallycontact and occlude filters 290, thereby requiring the use of morefilters. In view of the foregoing, using large diameter ports in thepresent system enables the system to handle large gas flow rates withminimal back pressure so as to avoid the risk of rupturing the polymericfilm and enables fluid to freely flow out of filter assembly 260 andinto condenser bag 102 or container 12 so as to extend the life offilters 290.

The gap distance D between filters 290 and sleeves 280, as previouslydiscussed, can also be selected to preclude or minimize back pressure.For example, with reference to a transverse cross section normal to thelongitudinal axis of filter 290 and extending through filter 290 andsleeve 280, the area of the cross section within the gap region thatencircles filter 290 (hereinafter “the gap area”) can be sufficientlylarge at all points along the length of filter 290 or over a selectlength of filter 290 so that no additional back pressure in created as aresult of the gas passing along the gap area. Rather, the back pressureis produced solely or substantially by the gas passing through filter290. To achieve the foregoing, in one embodiment the gap area is in arange equal to the area of gas intake port 266 or gas exhaust port168+/−10%, 15% or 20%. It is appreciated that it is not critical thatthe only back pressure be produced by gas passing through filter 290. Asmall amount of back pressure can also be produced by gas passingthrough the intake ports, exhaust ports and/or through the gap area aslong as the back pressure is not so great that it risks the safeoperation of container 12, condenser bag 102 or filter assembly 260.

Select embodiments of filter assembly 260 and other components also haveother benefits. For example, because filter assembly 260 is coupleddirectly to condenser bag 102, as opposed to being coupled with tubing,material costs and assembly time is reduced. Likewise, because bothcondenser bag 102 and filter assembly 260 are mounted to supporthousing, the system has a relative small footprint that occupies minimalspace. Furthermore, by keeping the elevation of condenser system 16relatively low, the maximum height of filter assembly 260 is minimized,thereby enabling use in low ceiling areas. The fluid processing systemcan operate under a large range of gas flow rates, thereby permittingthe processing of a variety of different types of fluid. The system isparticularly adapted for functioning as a fermenter that processesmicroorganisms due to the high gas flow rate required to growmicroorganisms. Furthermore, because the system operates at a relativelylow gas pressure, a less rigid containment structure is required and thesystem is safer to work around. The system and the components thereofalso have other advantages.

In the depicted embodiment, filter assembly 260 includes four sleeves280A-D and four corresponding filters 290A-D. The number of filters 290used is largely dependent on the volume of culture or other fluid beingprocessed. In alternative embodiments, filter assembly 260 can compriseone sleeve 280, two sleeves 280, three sleeves 280, or five or moresleeves 280 along with a corresponding number of filters 290. Forexample, depicted in FIG. 18 is an alternative embodiment of a filterassembly 260A that includes a single filter. Like features betweenfilter assemblies 260 and 260A are identified by like referencecharacters. Filter assembly 260A includes a casing 264A in the form ofan elongated linear tubular sleeve that bounds a compartment 270Aextending between a first end 364 and an opposing second end 366. Casing264A can be made from the same materials, such as polymeric films, andhave the same properties as discussed above with regard to casing 264.Intake port 266 is secured to first end 364 while exhaust port 268A issecured to second end 366. Filter 290A is secured to exhaust port 268Aand is disposed within compartment 270A in the same manner so as tooperate in the same way as discussed above with regard to filter 290A insleeve 280A (FIG. 17 ). Fill line 352 can be mounted on casing 264A soas to communicate with compartment 270A.

Depicted in FIG. 19 is another alternative embodiment of a filterassembly 260B that includes two filters. Like features between filterassemblies 260 and 260B are identified by like reference characters.Filter assembly 260B includes a casing 264B that bounds a compartment270B. Casing 264B can be made from the same materials, such as polymericfilms, and have the same properties as discussed above with regard tocasing 264. Casing 264B includes a tubular first sleeve 370 and atubular second sleeve 372. First sleeve 370 is linear and extendsbetween a first end 374 and an opposing second end 376. Intake port 266is secured to first end 374 while exhaust port 268A is secured to secondend 376. Filter 290A is secured to exhaust port 268A and is disposedwithin sleeve 370 in the same manner so as to operate in the same way asdiscussed above with regard to filter 290A in sleeve 280A (FIG. 17 ).Second sleeve 372 includes a first end 378 and an opposing second end380. First end 378 has an L-shaped curve that couples in fluidcommunication with first sleeve 370 at a location between the bottom offilter 290A and intake port 266. Exhaust port 268B is secured to secondend 380. Filter 290B is secured to exhaust port 268B and is disposedwithin second sleeve 372 in the same manner so as to operate in the sameway as discussed above with regard to filter 290A in sleeve 280A (FIG.17 ). Fill lines 352A and B can be mounted on sleeves 370 and 372 so asto communicate with the corresponding compartment sections. A filterassembly with three filters can be formed by securing a third sleeve,identical to second sleeve 372, on the opposing side of first sleeve 370and securing exhaust port 268C and filter 290C thereto.

In the above discussed embodiments, the filter assemblies can operate sothat gas is concurrently exiting out of each filter 290 duringoperation. In an alternative embodiment, one or more clamps can be usedto isolate one or more filters 290 from the gas flow. When the filter(s)in use begins to plug, the clamps can be released, either concurrentlyor in stages, to permit the gas to flow through the new filter(s). Forexample, depicted in FIG. 20 , a plurality of clamps 408A-C can bemounted on filter assembly 260. Specifically, clamp 408A extends acrossmanifold 278 between first sleeve 280A and second sleeve 280B; clamp408B extends across manifold 278 between second sleeve 280B and thirdsleeve 280C; and clamp 408C extends across manifold 278 between thirdsleeve 280C and fourth sleeve 280D. Clamps 408 can be moved between aclosed position that seals closed the section of manifold 278 over whichthe clamp extends so that gas cannot pass therethrough and an openposition which permits the gas to freely pass through manifold 278. Inone embodiment, clamps 408 can simply be clamps that are manually openedand closed.

During operation, gas is delivered to filter assembly 260 through intakeport 266. The gas travels up through second sleeve 280B, through filter290B and out through outlet port 268B. Clamps 408A and B preclude any ofthe gas from traveling out through filters 290A, C or D. As filter 290Bstarts to clog, the gas pressure within container 12, condenser bag 102and filter assembly 260 starts to increase. This pressure can bemeasured by a pressure sensor that communicates with the head space incontainer 12. However, the pressure sensor could also be incommunication with the gas at any location between container 12 andfilter 290B.

As previously discussed, filter assembly 260 is designed to operate at arelatively low gas pressure. Accordingly, as the gas pressure increases,there is an increased risk that casing 264, condenser bag 102 and/orcontainer 12 could fail due to rupture. Accordingly, when it isdetermined that the gas pressure has exceeded a predetermined value,either by sensing the gas pressure or otherwise determining the amountof clogging of filter 290B, clamp 408A can be opened, thereby decreasingthe gas pressure by allowing at least a portion of the gas to now passthrough filter 290A. The monitoring of the gas pressure is continued andwhen it again exceeds the predetermined value, clamp 408B is opened toagain decrease the gas pressure by allowing the gas to now flow outthrough gas filter 290C. If needed, clamp 408C can be opened to permitgas to pass out through gas filter 290D.

As previously mentioned, clamps 408 can be manual clamps. As such, asthe gas pressure increases, clamps 408A-C can be manually openedconsecutively. Alternatively, clamps 408A-C can be configured to openautomatically when the gas pressure exceeds the predetermined value. Forexample, in the depicted embodiment clamp 408A comprises a first arm410A hingedly coupled to a second arm 412B. A barbed latch 414A ispivotably mounted on first arm 410 and is configured to engage and lockwith second arm 412B by passing into an opening 416A on second arm 412A.That is, as latch 414A passes into opening 416, the barb on latch 414Acatches on the back side of second arm 412 so as to lock arms 410A and410B together. A solenoid 418A engages with latch 414A and selectivelymoves latch 414A between a catch position where latch 414A will engagewith second arm 412A and a release position where latch 414A downwardlypivots to disengage from second arm 412A. Solenoid 418A is controlled bya central processing unit (CPU) 420 through an electrical wire 422A.Clamps 408B-D have the same configuration as clamp A and are operated inthe same manner by being electrically coupled with CPU 420. CPU 420 isalso electrically coupled with a pressure sensor 424 that is coupledwith container 12 so as to detect the gas pressure within head space 162of container 12 (FIG. 2 ).

Accordingly, during initial operation, each clamp 408A-C is in theclosed position so that gas can only pass through filter 290B of sleeve280B. When CPU determines that the gas pressure within container 12exceed a predetermined value, CPU automatically moves latch 414A to therelease position. The gas pressure within casing 264 forces clamp 408Ato open and thereby allow gas to pass through filter 290A of sleeve280A. CPU 420 can then consecutively automatically open clamps 408B and408C, as needed, based on the level of gas pressure sensed in container12 through pressure sensor 424.

As previously mentioned, sensor 424 can also communicate with condenserbag 102 or with filter assembly 260 so long as it is measuring, eitherdirectly or indirectly, the gas pressure to which container 12,condenser bag 102 and filter assembly 260 are being subjected.Furthermore, the clamps, whether manual or automatic, can have a varietyof different configuration and methods of use. The clamps need only beable to clamp portions of casing 264 closed so that no gas can reach therestricted filters. The location of the clamps can also vary. Forexample, rather than placing clamps 408 on manifold 278, clamps 408could be placed across first end 282 of each sleeve 280 below thecorresponding filter 290. The same is also true for the alternativeembodiments of the filter assembly having only two, three, or othernumbers of filters.

By using the above clamping process to isolate the filters, only filtersthat are needed are used. It is desirable to limit the number of filtersused because no integrity testing, as discussed below, is required forunused filters. Furthermore, because filters are relatively expensive,if a filter is unused it could potentially be recycled and used in aseparate filter assembly.

Following the processing of a culture, standard processing techniquesrequire that filter(s) 290 be tested to ensure that the filtersfunctioned properly so that no contaminates could have accessed theculture within container 12 through filter assembly 260. In one methodof this integrity testing, each sleeve 280 with the corresponding filter290 is separated from the remainder filter assembly 260. Specifically,as depicted in FIG. 21 , a weld seam 426 is formed across manifold 278between sleeves 280A and 280B so that no gas can pass though seam 426.Weld seam 426 is typically formed by compressing the opposing sides ofmanifold 278 together, which is formed by polymeric film, and thenapplying heat energies, RF energies, sonics, or other sealing energiesacross the compressed polymeric film, as is known in the art, so as toweld the film together.

Once seam 426 is formed, a cut is then centrally made along the lengthof seam 426 so as to separate sleeve 280A and corresponding filter 290Afrom the remainder of filter assembly 260. Specifically, seam 426 isbisected by the cut so that a portion 428A of seam 426 remains on thesection of manifold 278 connected to sleeve 280A and a portion 428B ofseam 426 remains on the section of manifold 278 connected to sleeve280B. Both portions 428A and 428B of seam 426 independently form a gastight seal across their corresponding section of manifold 278. Oncesleeve 280A is removed, the integrity of filter 290A can be testedthrough a standard integrity testing method, such as through the bubblepoint test, diffusion test, pressure hold test or pressure decay test.For example, in one method clamp 360 is removed from fill line 352 andconnector 358 is coupled with a gas source 440 that delivers a gas, suchas air, and a component that will partially occlude the filter, such asethanol. Next, the gas and the filter occluding component are deliveredinto the compartment bounded within sleeve 280A through fill line 352.The gas is delivered until a predetermined pressure is reached. The rateat which the filter occluding component passes through filter 290 canthen be measured to determine the integrity of filter 290.Alternatively, the gas pressure can be monitored through a pressuregauge 442 for a predetermined period of time to determine if there isany loss in pressure or the rate of loss of pressure to determine theintegrity of filter 290.

In another method, fill line 352 is used to fill the compartment ofsleeve 280A with a detectable gas, such as helium, to a predeterminedpressure. Either before or after dispensing the detectable gas, theseparated sleeve 280A is enclosed within a sealed chamber of a detectorand a vacuum is applied to the chamber. The detector then senses for thepresence of the detectable gas within the chamber over a predeterminedperiod of time to determine the integrity of filter 290. It isappreciated that the integrity tests are standard and known in the artand that other integrity tests can also be used.

In the same manner that sleeve 280A and filter 290A therein is tested,each of the remaining sleeves 280B-D and corresponding filters 290B-Dcan also be tested by forming weld seams along lines 430A and B. Withregard to testing sleeve 280B and corresponding filter 290B, a gas tightcap can be connected to intake port 266 or a weld seam can be formedalong line 432 across inlet 276. In alternative embodiments the weldseams can be placed at different locations. For example, by upwardlymoving where each fill line 352 connects to a location higher on eachsleeve 280A-D, the weld seams could be formed across the first end ofeach sleeve 280A-D below the corresponding fill line 352, such as alonglines 434A-D. In the embodiments shown in FIGS. 18 and 19 , the weldseam can be formed along lines 436 or at other locations consistent withthe above discussion. Furthermore, in contrast to forming a single weldseam 426 and then bisecting the weld seam to separate the differentsleeves, two spaced apart weld seams can be formed and casing 264 cutbetween the weld seams. Likewise, a single weld seam 426 can be replacedby clamps with casing 264 being cut between the clamps. Other techniquescan also be used.

In alternative embodiments, it is appreciated that filter assembly 260can be connected to condenser bag using different techniques. Forexample, in FIG. 22 a single port 446 can be used to connect casing 264of filter assembly 260 to body 164 of condenser bag 102. Port 446includes an elongated stem 448 having an interior surface 449 and anexterior surface 452 that extend between a first end 450 and an opposingsecond end 452. Interior surface 449 bounds a port opening 453 thatextends therethrough and that can have a size and configuration the sameas the other port openings discussed herein. An optional alignmentflange 454 encircles and radially outwardly projects from exteriorsurface 452 of stem 448 at a central location between opposing ends 450and 452. First end 450 can be received and welded within outlet opening185 of body 164 of condenser bag 102 while second end 452 can bereceived and welded within inlet opening 267 of body 164 of filterassembly 260. As a result, port 446 forms direct fluid communicationbetween outlet opening 185 of condenser bag 102 and inlet opening 267 offilter assembly 260 without the use of a clamp.

In another alternative embodiment as depicted in FIG. 23 , body 164 ofcondenser bag 102 can be integrally formed with casing 264 of filterassembly 260 so that condenser bag 102 and filter assembly 260 are influid communication without the use of any clamp, port or other coupler.Specifically, as depicted in FIG. 23 , third leg 196 of body 164 isintegrally formed with inlet 276 of casing 264 so that third leg 196 andinlet 276 form a single continuous member 456. For example, body 164 andcasing 264 can be formed as a single continuous pillow bag formed fromtwo overlapping sheets of polymeric film that are welded together aroundtheir perimeter edge.

Depicted in FIG. 24 is another alternative embodiment of a filterassembly 260C. Like elements between filter assembly 260 and 260C areidentified by like reference characters. Filter assembly 260C isidentical to filter assembly 260 except that it is modular in design.Specifically, manifold 278 between sleeves 280A and 280B is connectedtogether by exhaust port 168 and intake port 266, previously discussed,that are mounted on opposing halves of the manifold section. Ports 168and 266 can be coupled together using clamp 273 to form as gas tightseal therebetween as also previously discussed. By using ports 168 and266 on manifold 278, any desired number sleeves 280 and filters 290 canbe easily added to filter assembly 260C during the manufacture stage.For example, a separate pair of ports 168 and 266 can be formed alongmanifold 278 between each pair of sleeves 280. In this configuration,any desired number of single sleeves 280 and corresponding filters 290can be sequentially added or removed in series, prior to sterilization,to form the desired filter assembly 260C.

Finally, in the embodiments previously depicted herein, condenser bag102 is coupled between container 12 and filter assembly 260. However, inan alternative use where the gas flow rate is very low so that only aminimal amount of moisture is being carried into condenser bag 102,condenser bag 102 and the remainder of condenser system 17 can beeliminated. According, as depicted in FIG. 25 , filter assembly 260 andall of the other alternative filter assemblies discussed herein can bedirectly coupled to exhaust port 92 on container 12. Furthermorealternative embodiments discussed herein of how condenser bag 102 can besecured to container 12, including the use of port 92A depicted in FIG.13 , are also applicable to how filter assemblies can be connected tocontainer 12.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

What is claimed is:
 1. A method for filtering a gas comprising: passinga gas through a compartment of a filter assembly, the filter assemblycomprising: an inlet opening; a first outlet opening; a casingcomprising polymeric film and bounding the compartment, the compartmentcommunicating with the inlet opening and the first outlet opening; and afirst filter at least partially disposed within the compartment; forminga first seal across a first section of the casing at a location betweenthe inlet opening and the first filter to form a first sub-compartmentwithin the casing; and severing the casing at a first location.
 2. Themethod as recited in claim 1, wherein forming the first seal comprisesforming a weld seal across the first section of the casing.
 3. Themethod as recited in claim 2, wherein severing the casing comprisescutting the casing along the weld seal so as to bisect the weld seal. 4.The method as recited in claim 1, wherein forming the first sealcomprises placing a clamp across the first section of the casing.
 5. Themethod as recited in claim 1, wherein the casing comprises a firstsleeve having the first outlet opening, the first filter being at leastpartially disposed within the first sleeve.
 6. The method as recited inclaim 1, wherein the filter assembly further comprises: a second filterat least partially disposed within the compartment.
 7. The method asrecited in claim 6, further comprising: forming a second seal across asecond section of the casing at a location between the inlet opening andthe second filter to form a second sub-compartment within the casing;and severing the casing at a second location.
 8. The method as recitedin claim 1, further comprising forming a second seal across a furthersection of the casing at a location between the inlet opening and thefirst filter, the second seal being spaced apart from the first seal. 9.The method as recited in claim 8, further comprising severing the casingat a location between the first and second seals, so as to separate afirst portion of the filter assembly from a remainder of the filterassembly, the first portion including the first sub-compartment and thefirst filter.
 10. The method as recited in claim 7, wherein the secondlocation is located between the second seal and the inlet opening. 11.The method as recited in claim 7, wherein the second location isproximate the second seal.
 12. The method as recited in claim 1, whereina distance between the inlet port and the first filter ranges between 4cm to 16 cm.
 13. The method as recited in claim 1, further comprising:dispensing a gas into the first sub-compartment; and testing anintegrity of the first filter using the gas dispensed in the firstsub-compartment.
 14. The method as recited in claim 13, wherein testingthe integrity of the first filter comprises a bubble point test, adiffusion test, a pressure hold test, or a pressure decay test.
 15. Themethod as recited in claim 1, further comprising a flexible fill linecoupled to the casing.
 16. The method as recited in claim 15, furthercomprising a tube clamp disposed on the flexible fill line.
 17. Themethod as recited in claim 15, wherein the flexible fill line isconnected to a gas source comprising a gas and an occluding componentthat can partially occlude the filter.
 18. The method as recited inclaim 17, wherein the gas is air and the occluding component is ethanol.19. The method as recited in claim 17, passing the occluding componentthrough the first filter, wherein a rate at which the occludingcomponent passes through the first filter determines an integrity of thefirst filter.
 20. The method as recited in claim 17, further comprising:passing the gas and the occluding component through the first filter ata predetermined pressure; and determining an integrity of the firstfilter based on a flow rate of the occluding component passing throughthe first filter.